化学药物技术评价体系构建中的思考

Some Thoughts on the Construction of Chemical Drug Evaluation System

关键词:  

Key words:  chemical drug  drug evaluation system  drug supervision  drug R&D; drug clinical use

摘要:

目的 探讨影响化学药物技术评价的几个关键因素，促进化学药物技术评价体系的科学构建。方法 从药品行政审批、药物研发、药物应用等方面与技术评价的关系入手，结合我国现状进行剖析。结果 明确了化学药物技术评价体系与药品行政审批、药物研发和药物应用之间的关系与相互作用。结论 化学药物技术评价贯穿于化学药物的整个生命周期，只有将评价工作与药物监管等多个方面有机结合，才能对药物进行准确评价并确保公众用药安全。

Abstract:

OBJECTIVE To identify the key facts which may influence drug evaluation procedure in order to build chemical drug evaluation system. METHODS Case studies were analyzed to demonstrate how the drug evaluation is influenced by the other points of drug managements: drug supervision, drug R&D and clinical use. RESULTS The relation and reaction between chemical drug evaluation system and the drug supervision, drug R&D, clinical use were confirmed. CONCLUSION Chemical drug evaluation plays an essential role in drug life cycle. Only combined with other facts of drug management, the drug evaluation can make the right evaluation and contribute to the safe and effective use of drug products for patients.